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Buprenex (Buprenorphine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS:

The most frequent side effect in clinical studies involving 1,133 patients was sedation which occurred in approximately two-thirds of the patients. Although sedated, these patients could easily be aroused to an alert state.

Other less frequent adverse reactions occurring in 5-10% of the patients were:

Nausea Dizziness/Vertigo

Occurring in 1-5% of the patients:

Sweating Headache

Hypotension Nausea/Vomiting

Vomiting Hypoventilation

Miosis

The following adverse reactions were reported to have occurred in less than 1% of the patients:

CNS Effect: confusion, blurred vision, euphoria, weakness/fatigue, dry mouth, nervousness, depression, slurred speech, paresthesia.

Cardiovascular: hypertension, tachycardia, bradycardia.

Gastrointestinal: constipation.

Respiratory: dyspnea, cyanosis.

Dermatological: pruritus.

Ophthalmological: diplopia, visual abnormalities.

Miscellaneous: injection site reaction, urinary retention, dreaming, flushing/warmth, chills/cold, tinnitus, conjunctivitis, Wenckebach block, and psychosis.

Other effects observed infrequently include malaise, hallucinations, depersonalization, coma, dyspepsia, flatulence, apnea, rash, amblyopia, tremor, and pallor.

The following reactions have been reported to occur rarely: loss of appetite, dysphoria/agitation, diarrhea, urticaria, and convulsions/lack of muscle coordination.

Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the postmarketing experience of Buprenex and other buprenorphine- containing products. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to buprenorphine is a contraindication to Buprenex.

In the United Kingdom, buprenorphine hydrochloride was made available under monitored release regulation during the first year of sale, and yielded data from 1,736 physicians on 9,123 patients (17,120 administrations). Data on 240 children under the age of 18 years were included in this monitored release program. No important new adverse effects attributable to buprenorphine hydrochloride were observed.



REPORTS OF SUSPECTED BUPRENEX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Buprenex. The information is not vetted and should not be considered as verified clinical evidence.

Possible Buprenex side effects / adverse reactions in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: 70 year old male

Reactions: OFF Label USE, Osteoarthritis, Arthritis Infective

Adverse event resulted in: hospitalization

Suspect drug(s):
Buprenorphine
    Dosage: dosing details unknown
    Indication: Drug Dependence
    End date: 2011-05-01

Buprenex
    Dosage: dosing details unknown
    Indication: Drug Dependence
    End date: 2011-05-01

Other drugs received by patient: Blood Pressure Pill



Possible Buprenex side effects / adverse reactions in 53 year old male

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 53 year old male

Reactions: OFF Label USE, Pneumonia, Drug Withdrawal Syndrome

Adverse event resulted in: hospitalization

Suspect drug(s):
Suboxone
    Dosage: 16 mg
    Indication: Drug Dependence
    Start date: 2007-01-01
    End date: 2012-05-20

Buprenex
    Dosage: 4 times per day
    Indication: Drug Dependence
    Start date: 2012-05-21

Other drugs received by patient: Klonopin



Possible Buprenex side effects / adverse reactions in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-06-13

Patient: 70 year old male

Reactions: OFF Label USE, Osteoarthritis, Arthritis Infective

Adverse event resulted in: hospitalization

Suspect drug(s):
Buprenorphine
    Dosage: dosing details unknown
    Indication: Drug Dependence
    End date: 2011-05-01

Buprenex
    Dosage: taking 5 vials a day - unknown dosing info
    Indication: Drug Dependence
    Start date: 2007-01-01
    End date: 2012-04-01

Buprenex
    Dosage: taking 5 vials a day - unknown dosing info
    Indication: Pain
    Start date: 2007-01-01
    End date: 2012-04-01

Other drugs received by patient: Blood Pressure Pill



See index of all Buprenex side effect reports >>

Drug label data at the top of this Page last updated: 2014-02-21

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